Pharmacokinetics and Metabolism of [14C] BMS-986195 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Ratio of AUC0-inf of plasma TRA relative to blood TRA (%)
研究概览
简要总结
The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects, if not surgically sterilized, must agree to use adequate contraception
- •Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive (BMI = weight [kg]/[height (m)]2), and total body weight >50 kg
- •All prescribed medication, including live vaccinations, must have been stopped at least 30 days prior to admission to the clinical research center
- •All over-the-counter (OTC ) medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the clinical research center
- •Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks), and grapefruit (juice) from 3 days prior to admission to the clinical research center
- •Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the Principal Investigator
排除标准
- •Previous participation in the current study
- •Known previous exposure to BMS-986195
- •Employee of PRA or the Sponsor
- •History of relevant drug and/or food allergies, including allergy to immunologic or related compounds or allergy to seafood or marine products
- •Using tobacco products within 60 days prior to drug administration
- •Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
BMS-986195
A single oral solution dose of BMS-986195
干预措施: BMS-986195 (Drug)
结局指标
主要结局
Ratio of AUC0-inf of plasma TRA relative to blood TRA (%)
时间窗: Up to 16 days
Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces
时间窗: Up to 16 days
Percentage of estimated part for the calculation of AUC0-inf (%AUCextra)
时间窗: Up to 16 days
Apparent oral clearance, calculated as dose/AUC0-inf (CL/F)
时间窗: Up to 16 days
Cumulative amount of TRA excreted in feces (Aefeces)
时间窗: Up to 16 days
Fraction of the dose administered excreted in urine (feurine)
时间窗: Up to 16 days
Maximum observed plasma concentration (Cmax)
时间窗: Up to 16 days
Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Ĉlast/kel [AUC(0-inf)]
时间窗: Up to 16 days
Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%)
时间窗: Up to 16 days
Cumulative amount of TRA excreted in bile (Aebile)
时间窗: Up to 16 days
Fraction of the dose administered excreted in feces (fefeces)
时间窗: Up to 16 days
Fraction of the dose administered excreted in urine and feces (fetotal)
时间窗: Up to 16 days
Terminal elimination rate constant (kel)
时间窗: Up to 16 days
Fraction of the dose administered excreted in bile (febile)
时间窗: Up to 16 days
Time to attain maximum observed plasma concentration (tmax)
时间窗: Up to 16 days
Area under the plasma concentration-time curve up to time t, where t is the last point with concentrations above the lower limit of quantitation [AUC(t-0)]
时间窗: Up to 16 days
Terminal elimination half life, calculated as 0.693/kel (t1/2)
时间窗: Up to 16 days
Apparent volume of distribution at terminal phase (Vz/F)
时间窗: Up to 16 days
Cumulative amount of TRA excreted in urine (Aeurine)
时间窗: Up to 16 days
次要结局
- QTc-interval (Fridericia's) measured by ECG(Up to 16 days)
- Number of serious adverse events (SAE)(Up to 16 days)
- Number of laboratory test result abnormalities(Up to 16 days)
- PR-interval measured by ECG(Up to 16 days)
- QT-interval measured by ECG(Up to 16 days)
- Number of adverse events (AE)(Up to 16 days)
- QRS-duration measured by ECG(Up to 16 days)
- Heart rate measured by ECG(Up to 16 days)